Medical Technology Regulatory Affairs
This programme is being made available online using a combination of distance-learning/e-learning technologies and some face-to- face workshops for an overall blended learning approach. The educational elements are provided by the Institute of Technology, Sligo, and NUI Galway staff. Additional lecturing, as required, may be provided by outside specialists and practitioners. The programme consists of 12 modules, each of 5 ECTS, delivered over two years (six modules per year), and a research project (30 ECTS), carried out over both years of the programme.
3 Good Reasons To Study This Course
1. Flexible part-time online programme for medtech regulatory affairs professionals. Designed and delivered by regulatory affairs experts, supported by industry RA professionals. Supported by medical technologies industry representative organisations.
2. This course will equip you with the essential knowledge, skill set and competencies to function as a regulatory affairs professional in the medical device industry and contribute to regulatory projects in a medical device company
3. Participants can provide strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safe and effective healthcare products to people around the world.
Minimum Entry Requirements
Candidates must hold at least a Second Class Honours Level 8 primary degree in a related subject area in science or engineering. Prior medical technology industry experience in regulatory affairs will be considered a distinct advantage in assessing applications. Applications from candidates who hold a relevant degree at Level 7, with at least two years' medical technology industry experience in regulatory affairs, will also be considered.
2 years, part-time distance-learning.
Post Course Info
Graduates will be equipped with essential knowledge and skills to work in a regulatory affairs environment within the medical technology industry sector. The Irish Medical Devices Association (IMDA) states that the medical technology sector employs over 25,000 people, with 18 of the world's top 25 medical technology companies maintaining a base in Ireland and a further 50% of the 300 medtech companies being indigenous. The sector is expected to continue to grow, as stated by the director of the IMDA Sinead Keogh: "IMDA's latest survey shows that confidence within the sector is improving steadily, with nearly half of companies more confident now than they were three months ago and nearly half planning to hire new staff."